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The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
STUDY DESIGN:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool Collection and Survey Completion | Other | Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact. The biospecimens collected from participants on this study are stool samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective- Intestinal side effects of chemotherapy | The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population. | 8 months |
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Cohort 1: Colorectal Cancer
Inclusion:
Exclusion:
Participants who are pregnant or are nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
Subjects who are currently in remission for CRC.
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Patients with active colorectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Andrew C Frisina, M.S. | Sanguine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanguine Biosciences, Inc. | Woburn | Massachusetts | 01801 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |